Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Ali/Amlo 150/2.5 mg

• Registration Number: NCT01237873
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Study Start: 2011-01
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients that complete CSPA100A1301 study
• Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria

• Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
• Presence of major protocol violation in CSPA100A1301 study

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ali/Amlo	Ali/Amlo 150/2.5 mg	Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Primary Outcome Measures

Name	Time	Method
Long-term safety of the fixed-dose combination of aliskiren/ amlodipine	52 weeks	Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.

Secondary Outcome Measures

Name	Time	Method
Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.	52 weeks	this endpoint will measure the change from baseline for mean sitting diastolic blood pressure, mean sitting systolic blood pressure, supine diastolic blood pressure, supine systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure.
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study	52 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Toshima-ku, Tokyo, Japan